Therapeutic Areas

Twenty-four disease areas. One senior team.

Consultants who know your science, your endpoints, and your division of the agency — not just the regulations around them. We staff by the biology of your program, not a generalist rotation.

  • 24Disease areas
  • 4FDA centers & offices
  • End⁠-⁠to⁠-⁠endIND to approval
Physician reading a wall of brain MRI and CT scans

Depth, not coverage

Regulations are the same for everyone. The review isn’t.

A reviewer in oncology weighs a surrogate endpoint differently than one in cardiology. A rare-disease division reads a 40-patient dataset differently than an anti-infectives team reads 4,000. The rulebook is public; the way each division applies it is learned.

Our consultants have sat on the other side of those meetings — in the therapeutic area you’re working in, at the center that will review you. So the strategy we bring already anticipates the questions your program will actually get asked.

The Directory

Find your indication

Twenty-four areas of deep expertise. Each links to how we think about its science, its endpoints, and its regulatory path.

  • Portrait of a child using an oxygen mask indoors, highlighting health care needs
    AnesthesiologyBeating a baseline that almost never fails.
  • Cardiac monitor displaying vitals on a clinical cart
    CardiovascularOutcomes-scale programs and combination CV devices.
  • High-resolution image of a modern defibrillator in a hospital environment
    Critical CareSepsis, consent by exception, and the hardest trials in medicine.
  • Dental models with teeth arrangement on a table, ideal for health and education visuals
    Dentistry & Oral HealthCosmetic, drug, or device — the claim decides.
  • Patient showing a dermatologic condition at the collarbone
    DermatologyTopicals, biologics, and aesthetic-medical crossovers.
  • Glucose meter, lancet, and syringes arranged on a lilac surface
    Endocrinology & Metabolic DisordersDiabetes and obesity, and the device-drug border they live on.
  • Anatomical model with sticky notes and drawings on a white wall, depicting internal organs
    GastroenterologySymptom diaries and centrally read mucosal healing.
  • Close-up of surgical instruments prepared for surgery in a hospital operating room
    General SurgeryCleared in months, judged for a decade.
  • Syringe resting across vaccine vials
    Infectious DiseasesVaccines and anti-infectives, first trial to licensure.
  • Close-up of a surgeon operating in a sterile environment using surgical instruments
    Minimally Invasive SurgeryWhen the instrument becomes a software platform.
  • Focused shot of a patient's hand with IV in a hospital setting
    Nephrology & Renal CareThe field that finally got a surrogate.
  • Research participant wearing an EEG headset
    NeurologyNovel mechanisms and endpoints the agency will question.
  • CT scanner in a bright modern imaging suite
    OncologySolid tumor and heme-onc, IND through accelerated approval.
  • Patient examined at a slit lamp in an eye clinic
    OphthalmologyFront and back of the eye — drugs, devices, combinations.
  • Surgeon performing arthroscopic knee surgery using specialized equipment
    OrthopedicsImplants judged in decades, cleared on the bench.
  • A medical professional examines a patient's ear using a Heine otoscope, highlighting healthcare quality
    Otolaryngology (ENT)From a retail shelf to a cochlear implant PMA.
  • Side view of a man holding his neck in pain against a black background
    Pain ManagementFour gates: efficacy, abuse, scheduling, REMS.
  • A medical professional examines a newborn baby indoors, highlighting healthcare and care
    PediatricsThe study you must do, and the six months it buys.
  • Scientist carrying a rack of samples through a genetics laboratory
    Rare DiseasesOrphan designations, small populations, big evidentiary questions.
  • Crop unrecognizable orthopedist in uniform and wristwatch supporting shoulder and reached arm of faceless female patient with resistance band in doctor office
    Rehabilitation MedicineClearance is the cheap half. Coverage is the battle.
  • Clinicians beside an anesthesia and ventilation workstation
    RespiratoryInhaled combinations and device-dependent delivery.
  • Close-up of hands holding a urine specimen container in a lab environment
    UrologySplit between the scalpel and the symptom score.
  • Expecting mother reviewing results with her clinician
    Women’s HealthLong-underserved indications, finally getting programs.
  • Close-up of two people bandaging an injured hand outdoors, focusing on first aid care
    Wound CareClosed, or not closed — and the 361/351 question.

Know your reviewer

Every indication has a home at the agency.

Your therapeutic area determines which FDA center or office reviews your submission — and each reads the evidence its own way. We place consultants who have worked inside the one that will read yours.

Linear accelerator radiotherapy machine in a treatment suite OCE

Oncology Center of Excellence

Coordinates oncology review across the drug, biologic, and device centers — the through-line for solid-tumor and hematologic malignancy programs.

  • Oncology
  • Hematology
Pharmaceutical tablets on a dark reflective surface CDER

Drugs — CDER

Small molecules and most therapeutic biologics. The review divisions here run the majority of chronic-disease and specialty programs.

  • Immunology
  • Cardiovascular
  • Neuroscience
  • Endocrine
  • Respiratory
  • Dermatology
Scientists in full protective gowning inside a biologics cleanroom CBER

Biologics — CBER

Vaccines, blood products, and the advanced therapies — cell, gene, and live biotherapeutics — where precedent is thin and the science moves fastest.

  • Vaccines
  • Cell & Gene
  • Microbiome
State-of-the-art operating room equipped with advanced surgical devices CDRH

Devices & Diagnostics — CDRH

Devices, in-vitro diagnostics, and software as a medical device — plus the device constituent of every combination product.

  • Medical Devices
  • Digital Health
  • Diagnostics

Working a combination product or companion diagnostic? Those cross center lines — and the hand-off is where programs stall. We staff for the intercenter path, not just the lead center.

Don’t see your indication? The team is deeper than the page.

Tell us the molecule, the modality, and the meeting on your calendar. We’ll match you to consultants who have been in that room.

Start the Conversation